AMGN · 10-Q · 2026Q3 · Full report
Drug Pricing Policy Impact
AMGEN INC · 2026-11-04 · Importance 40 · Surprise 42
Amgen states that the Inflation Reduction Act (IRA) and expanded use of 340B discounts have negatively affected, and are likely to continue to negatively affect, its business. CMS selected ENBREL for Medicare price setting beginning in 2026 and Otezla beginning in 2027. Amgen says it took actions announced in December 2025 to satisfy components of the July Most-Favored-Nation (MFN) Letter, including the Administration’s pricing requests, and expanded its direct-to-patient program. CMS’s GENEROUS Model will provide additional supplemental rebates for certain drugs to participating state Medicaid programs; by September 2026, all 50 states, the District of Columbia and Puerto Rico had applied, while the ultimate effects on pricing, reimbursement, net sales and profitability remain uncertain.
Key facts
- Under the GENEROUS Model, Amgen and other participating manufacturers will provide additional supplemental rebates for certain drugs to participating state Medicaid programs, designed to align Medicaid net prices with prices in select other countries. source
- Amgen announced in December 2025 that it was taking actions satisfying components outlined in the July MFN Letter, including the Administration’s MFN pricing requests. source
- Amgen announced expansion of its direct-to-patient program in December 2025. source
- In September 2026, CMS announced that all 50 states, the District of Columbia and Puerto Rico had applied to participate in the GENEROUS Model. source
- Amgen said IRA provisions and expanded utilization of the 340B Program from broadened application of 340B discounts have negatively affected, and are likely to continue to negatively affect, its business. source
- Amgen said the ultimate effects of evolving pricing policy expectations on its pricing, reimbursement, net sales and profitability remain uncertain. source
- Amgen said healthcare-provider cost containment measures and significant pricing pressures have resulted in net price declines. source